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Sphingosine-1-Phosphate Receptor Modulator

Etrasimod for Eczema

Phase 2 & 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic AD (also known as atopic eczema) that was diagnosed at least 1 year prior to Screening and meets Hanifin and Rajka criteria at screening
Age 18-80 at screening (or minimum age of consent according to local regulations)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 68 weeks in part 1 and up to 52 weeks in part 2
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of etrasimod, a pill taken once daily, to treat moderate-to-severe atopic dermatitis (eczema) in adults who tried treatments that work all over the body and saw no effects. Participants will visit the clinic 6-12 times over 16-68 weeks, with tests for signs/symptoms, blood samples and vital signs.

Who is the study for?
Adults aged 18-80 with moderate to severe atopic dermatitis (AD), also known as eczema, who have not seen improvement after trying systemic therapies. Participants must have had AD for at least a year and be willing to use daily moisturizers throughout the study.Check my eligibility
What is being tested?
The trial is testing Etrasimod, an oral medication, against a placebo in adults with AD. Part 1 randomly assigns participants to either drug or placebo for 16 weeks; some may continue Etrasimod for another 52 weeks. Part 2 involves all participants taking Etrasimod for one year.See study design
What are the potential side effects?
Potential side effects of Etrasimod include reactions related to immune system changes since it affects how certain cells work in the body. This could lead to increased risk of infections or other immune-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with chronic eczema for over a year.
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I am between 18 and 80 years old.
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My eczema is moderate to severe, covering more than 10% of my body.
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I have tried a treatment for my condition before and it didn't work.
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I am willing to apply a skin moisturizer daily for at least one week before the study starts and will continue to do so throughout the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 68 weeks in part 1 and up to 52 weeks in part 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 68 weeks in part 1 and up to 52 weeks in part 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 DB: Proportion of participants achieving IGA of clear (0) or almost clear (1) (on a 5-point scale) and a reduction of ≥ 2 points from baseline
Part 1 OLE and Part 2: Incidence and severity of treatment-emergent adverse events (AEs), AEs leading to study treatment discontinuation, serious AEs, and AEs of special interest.
Part 1 OLE and Part 2: Incidence of clinically significant changes in AP, ALT (SGPT), AST (SGOT) (U/L)
+18 more
Secondary outcome measures
Part 1 DB: Percent change from baseline in EASI
Part 1 DB: Proportion of participants achieving a EASI-75

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: etrasimodExperimental Treatment1 Intervention
2 mg, oral tablet, once daily
Group II: Placebo (Part 1 DB period only)Placebo Group1 Intervention
Oral sham comparator

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,562 Previous Clinical Trials
10,906,721 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,471 Previous Clinical Trials
8,088,117 Total Patients Enrolled

Media Library

Etrasimod (Sphingosine-1-Phosphate Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT05732454 — Phase 2 & 3
Atopic Dermatitis Research Study Groups: etrasimod, Placebo (Part 1 DB period only)
Atopic Dermatitis Clinical Trial 2023: Etrasimod Highlights & Side Effects. Trial Name: NCT05732454 — Phase 2 & 3
Etrasimod (Sphingosine-1-Phosphate Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05732454 — Phase 2 & 3
Atopic Dermatitis Patient Testimony for trial: Trial Name: NCT05732454 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research require participants to be of legal age?

"The qualifications for this medical trial necessitate that participants lie between 18 and 80 years old. There are 105 trials dedicated to minors under the age of 18, and 170 specifically catering towards seniors over 65 years in age."

Answered by AI

Does my background qualify me to partake in this experiment?

"The requirements to be admitted into this medical trial include having a diagnosis of atopic dermatitis and being between 18-80 years old. There is capacity for approximately 400 individuals to participate."

Answered by AI

How many venues are currently hosting this clinical trial?

"Akumin Imaging in Tampa, Michigan, Clinical Research Trials of Florida in Lathrup Village, South dakota, and Tampa Eye Clinic in Troy, Texas are among the 10 clinical sites administering this trial."

Answered by AI

What is the present size of this research project's participant population?

"This study necessitates the inclusion of 400 eligible patients. Participants can enroll at Akumin Imaging in Tampa, Michigan and Clinical Research Trials of Florida in Lathrup Village, South dakota."

Answered by AI

Are there any opportunities for patient enrolment in this investigation?

"Clinicaltrials.gov confirms that recruitment for this clinical trial is ongoing, beginning on January 18th 2023 and most recently updated February 7th 2023."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Arlington Research Center
Ziaderm Research, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I have take a pain reliever but nothing specific for osteoarthritis.
PatientReceived no prior treatments
~267 spots leftby Sep 2026